Case Study 11

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For each question, choose the answer you think is correct. See the end of this page for the answers.

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A.P. is a 50-year-old female diagnosed with metastatic breast cancer with a primary lesion in the left breast and disease involving bones, lungs and liver. Tumour is ER-positive, PR-positive, and HER2-negative. She has pain in her right upper quadrant radiating towards the left scapula. She is also on pamidronate. She will be starting treatment with UBRAVPALAI.

Lab results taken 24 hours prior to first treatment:

Lab value

Patient's labs

Normal range

WBC

3.3

4 – 10 x 109/L

ANC

1.7

2 – 7.5 x 109/L

Hgb

142

115 – 155 g/L

Plt

190

150 – 400 x 109/L

SCr

54

45 – 90 umol/L

eGFR

93

≥ 60 mL/min/1.73m2

GGT

34

<49 U/L

AST

26

<36 U/L

ALT

32

<36 U/L

ALP

128

35 – 120 U/L

Total bilirubin

7

<17 umol/L

LD

156

<225 U/L

Weight = 53.8 kg, Height = 160 cm

1. Which of the following patient populations would be eligible to receive palbociclib?

2. What is the standard dosing regimen of palbociclib?

One tablet PO once daily continuously until disease progression or unacceptable toxicity

One tablet PO once daily for 3 weeks, then 1 week off until disease progression, unacceptable toxicity, or a maximum of 2 years of treatment

One tablet PO once daily for 3 weeks, then 1 week off until disease progression or unacceptable toxicity

One injection given subcutaneously every 3 months until disease progression or unacceptable toxicity

3. On day 15 of Cycle 1, A.P's bloodwork reveals the following: ANC = 0.8 x 109/L, Platelets = 100 x 109/L. Per protocol, she continues treatment at the same dose. Hematology is repeated on day 22: ANC = 0.7 x 109/L, Platelets = 105 x 109/L. Per protocol, which of the following would be the most appropriate treatment plan?

Nothing; there are no dose modifications based on Cycle 1 Day 22 bloodwork

Delay the start of Cycle 2 by 1 week; provided ANC recovers to ≥ 1 x 109/L, resume treatment at the same dose

4. A.P. returned to clinic in anticipation of Cycle 2 with Day 1 blood work reporting: ANC = 0.4 x 109/L, Platelets = 100 x 109/L. Her treatment was delayed for 1 week. Repeat bloodwork now reports: ANC = 1.1 x 109/L, Platelets = 153 x 109/L. Per protocol, which of the following would be the most appropriate treatment plan?

Resume treatment at the same dose as previous, 125 mg/day

Resume treatment at the next lower dose, 100 mg/day

Delay treatment for 1 more week, then resume at the same dose as previous, 125 mg/day

Resume treatment at the next lower dose of 75 mg/day

5. Which of the following would best explain why A.P. is also receiving pamidronate (Protocol code: BRAVPAM)?

She has symptomatic hypocalemia

She has a history of atypical femoral fracture

She is experiencing acute bone pain

She has a diagnosis of osteopenia

6. A.P. now returns to clinic in anticipation of Cycle 8, but without any bloodwork. Based on the protocol, would it be okay for her to proceed with treatment today without current labs?

Yes; after cycle 7, CBC monitoring is no longer required

Yes; results from Cycle 7 are available and CBC won't be repeated again until Cycle 10

No; CBC should be monitored with each subsequent cycle

Yes; results from Cycle 7 are available and CBC won't be repeated again until Cycle 9

Rationale: As per the revised eligibility of UBRAVPALAI after PALMOA-3 trial results were published, women who are on concurrent ovarian suppression (with LHRH agonists) are also eligible to receive treatment.

Rationale: As per the tests section of the protocol, CBC monitoring requirements for Cycle 7 onwards are based on ANC values from Cycles 1-6, with the ANC threshold being 1 x109/L. During the first 6 cycles of treatment, A.P.'s ANC dropped below 1 x109/L, and therefore, per protocol, CBC should continue to be monitored with each cycle of treatment.